EP2308550A1 - Epicardial stimulation/defibrillation probe with screw, suitable for implantation via a catheter-guide inserted in the pericardial cavity - Google Patents
Epicardial stimulation/defibrillation probe with screw, suitable for implantation via a catheter-guide inserted in the pericardial cavity Download PDFInfo
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- EP2308550A1 EP2308550A1 EP10174448A EP10174448A EP2308550A1 EP 2308550 A1 EP2308550 A1 EP 2308550A1 EP 10174448 A EP10174448 A EP 10174448A EP 10174448 A EP10174448 A EP 10174448A EP 2308550 A1 EP2308550 A1 EP 2308550A1
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- Prior art keywords
- probe
- screw
- assembly
- guide catheter
- probe head
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Images
Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/02—Details
- A61N1/04—Electrodes
- A61N1/05—Electrodes for implantation or insertion into the body, e.g. heart electrode
- A61N1/0587—Epicardial electrode systems; Endocardial electrodes piercing the pericardium
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/0021—Catheters; Hollow probes characterised by the form of the tubing
- A61M25/0041—Catheters; Hollow probes characterised by the form of the tubing pre-formed, e.g. specially adapted to fit with the anatomy of body channels
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
- A61M25/06—Body-piercing guide needles or the like
- A61M25/0662—Guide tubes
Definitions
- the invention relates to "active implantable medical devices" as defined by the Council of European Communities Directive 90/385 / EEC of 20 June 1990, in particular implants for continuously monitoring the heart rate and delivering, if necessary, the heart of electrical pulses of stimulation, resynchronization, or defibrillation.
- stimulation probes that is to say the delivery of low energy pulses, used for bradycardia or resynchronization therapy.
- the invention also applies to epicardial cardioversion / defibrillation probes intended to deliver high energy electrical shocks to the heart in an attempt to terminate a tachyarrhythmia.
- the generic term "stimulation / defibrillation probe (or electrode)” will be used to refer to any type of probe that can be used for these purposes.
- the epicardial probes can be especially prescribed for the stimulation of the left ventricle, as an alternative to the stimulation probes implanted via the coronary sinus, which require for their installation a delicate approach and are not without various disadvantages.
- an epicardial probe is a very invasive operation, generally requiring general anesthesia and the use of surgical techniques. It is indeed necessary for a surgeon to incise the thorax so as to allow access to the "pericardial sac" (the pericardium being the fibroserous envelope which envelops the heart), then to the myocardium itself, in order to fix the probe on the outer wall of the latter, by suturation or by screwing.
- sutured probes are very stable, but they require wide access (to allow suture by the surgeon), and the possible pose area, restricted to the proximity of the thoracic incision, is very limited.
- Screw probes have also been proposed.
- the screwing can be done directly, but the working area will be limited in the same way as for a sutured probe. It can also be done by means of a laying instrument comprising a handle, a telescopic support tube and an articulated head on which is mounted the probe. In the latter case, the surgeon will be able to access sites located beyond the incision, but the possible pose area will however be limited by the rigidity of the support tube of the instrument, and by the large diameter of this tube ( of the order of 40 French), which the doctor must advance in the curved pericardial space.
- the screw probes proposed so far have low electrical performance due to the large size of the screw (necessary to support the conditions of installation but does not provide a satisfactory current density).
- these fixation screws are relatively traumatic for the tissues, with the risk of locally creating reactive fibrosis.
- the screws of current probes are oversized, because of the high stresses exerted when laying on the screw, with very bulky accessories and low sensitivity.
- the probe head is subjected to significant mechanical stresses due to high displacement amplitudes, combined with radial tractions exerted via the probe body.
- the mechanical anchoring of the probe head on the myocardium must therefore be able to withstand these various constraints.
- the probe body (the sheath connecting the probe head to the stimulation generator) connects at right angles to the probe head, ie that is, that the axis of the sheath is perpendicular to the axis of the screw. This gives the whole a voluminous configuration, so traumatic in the region of the stimulation site.
- the basic principle of the invention is to choose as an epicardial probe a screw probe, but whose screw extends in the extension of the probe body (and no longer at 90 ° relative to the latter), with a screw similar in size and characteristics to endocavitary screw probes.
- the invention further proposes, for the establishment of such a probe on the outer wall of the myocardium, to use as a setting tool a guide catheter into which the probe will be slid.
- This catheter-guide can be introduced into the pericardial space by a simple puncture (thus without incision of the pericardial envelope), and it will be possible to make it evolve around the surface, approximately spherical, of the myocardium, to "navigate" and on the epicardium safely (because of the flexibility of the guide catheter and its soft tip tip atraumatic) to the chosen site of stimulation, which can be very far from the puncture constituting the access point to the pericardial space.
- the US 2008/0208166 A1 describes a preformed delivery endocardial catheter, with a double curvature forming a heart-wrapping segment intended to envelop the outer surface of the heart by including the latter on most of the epicardium.
- Such a catheter if combined with a screw probe, would certainly allow screwing but would very significantly limit the ability to evolve over a wide region on the surface of the heart. Indeed, the broad curves of the heart-wrapping tend permanently to coincide with the external form of the heart, by the principle of less energy. This results in a given equilibrium position (thus a given implantation site) for a given curvature, hence the need for several models (different curvatures) if one wants several possible implantation sites.
- WO 03/086502 A2 uses a guide wire previously introduced into the pericardial space, and anchored at its distal end in the wall of the myocardium. A probe provided with surface electrodes is then threaded on this guide wire to the chosen implantation site.
- the small dimensions of the catheter and the catheter-guide (typically of the order of 6 to 9 French), combined with the isodiametry of the probe, make it enough for a simple puncture to introduce the catheter guide and the probe, without incision of the pericardial sac.
- the monodiameter character of the probe is very favorable to the extraction, which can be operated simply by unscrewing and withdrawal, without heavy surgery.
- the assembly of the invention comprises, in a manner known per se, an epicardial probe of stimulation / defibrillation type screw probe, comprising: a probe body with a sheath of deformable material; distal side, a probe head with a stimulation / defibrillation electrode and a protruding helical anchoring screw adapted to penetrate the outer wall of the myocardium under the effect of a screwing motion printed at the probe head; and proximal side, coupling means to the generator of the medical device.
- the set also includes a fitting accessory for this epicardial probe.
- the probe is a monodiameter probe with the helical anchoring screw extending axially the probe head
- the fitting accessory is a removable guide catheter adapted to be introduced into the pericardial space.
- This guide catheter comprises a hollow tube open at both ends with a central lumen within which the probe is adapted to be introduced and moved in translation inside the guiding catheter, first up to a retracted position where the probe head is flush with the outlet distal side of the lumen of the guide catheter, and then to an extended position where the probe head, with the anchor screw, emerges from this outlet.
- the hollow tube of the guide catheter is a preformed tube, elastically deformable and relatively more rigid than the sheath of the probe body, and presenting in the absence of solicitation two successive curvatures inscribed in two distinct respective surfaces.
- the least distal curvature is a curvature adapted to allow a bearing of the probe body against the outer wall of the pericardial space
- the most distal curvature is a curvature adapted to allow orientation of the end of the catheter tube in the direction of the outer wall of the myocardium, and maintaining the axis of the anchor screw in the same direction during a combined movement of screwing and moving the probe head to the deployed position.
- the anchoring screw may be a fixed screw, or a movable screw, retractable in a housing of the probe head. It may be an active pacing / defibrillation electrode screw, or a passive screw, electrically decoupled from the pacing / defibrillation electrode.
- the sheath of the probe body may be chosen to have a torsion rigidity sufficient to allow transmission over its entire length of a rotational movement printed from the proximal end of the probe for screwing the anchor screw.
- the assembly will also comprise a removable mandrel capable of being introduced into a lumen of the probe body and movable in translation inside this lumen to the probe head and comprising coupling means. in rotation with the probe head, the mandrel having a torsion sufficient rigidity to allow transmission, over its entire length and up to the coupling means, a rotational movement printed from the proximal end of the mandrel, for the screwing in the anchor screw.
- the diameter of the guide catheter is less than or equal to 9 French, preferably less than or equal to 6 French, and that of the probe body is less than or equal to 5 French.
- the anchoring screw comprises an end portion adapted to penetrate into the outer wall of the myocardium, and connected to the probe head by a transition portion that is mechanically deformable in flexion, in particular a portion with contiguous turns of the helical screw. .
- the anchoring screw may also comprise an end portion adapted to penetrate the outer wall of the myocardium, and itself comprising an active region of electrically conductive tip, extending a portion electrically isolated intermediate, the axial length of which is preferably at most 1 mm.
- these form part of a parallelepiped volume of dimensions between 15 ⁇ 10 ⁇ 5 mm and 25 ⁇ 15 ⁇ 5 mm, compatible with the positioning in the pericardial space and the desired functions of holding and guiding the probe head.
- the reference 10 generally designates the screw probe of the assembly according to the invention.
- This probe 10 comprises a probe body 12 of structure in itself known, generally a polyurethane sheath to limit friction when the probe is introduced. in a guide catheter, and to provide better sensitivity and torque transmission.
- the diameter of the sheath of the probe body 12 is chosen sufficiently thin (typically less than or equal to 5 French) to be compatible with the dimensions of the pericardial space and with the diameter of the usual guide catheters.
- the probe 10 is terminated at its distal end by a helical anchoring screw 14 made of conducting material, connected via a metal tip 16 to an inner conductor 18 such as a spiral conductor providing electrical continuity between the screw anchor, which serves as a stimulation electrode and / or collection, and the generator located at the proximal end (not shown) of the probe.
- the polyurethane sheath may be selected to provide torsional rigidity to the probe body 12, so that torque can be transmitted from the proximal end to the distal end to rotate. the screw 14 to make it penetrate by screwing into the heart tissue.
- the anchor screw 14 is here an axial screw, that is to say that it extends in the extension of the probe body 12, thus providing the assembly with an overall configuration of the "isodiameter” or “monodiameter” type.
- the screw 14 is advantageously made with a distal portion formed, over a length of the order of 1.5 to 2 mm, non-contiguous turns 20 connected to the probe body via a mechanical transition portion having a flexural flexibility, for example a portion formed of turns 22 contiguous in the absence of stress on the screw.
- the screw 14 is advantageously isolated over its entire length, for example by a parylene coating, with the exception of the last distal millimeter, which will therefore be the only electrically active part of the screw, which makes it possible to reduce the stimulation surface and increase all the current density and therefore the electrical efficiency of the probe.
- This electrically active part will also be buried deep enough in the wall of the epicardium, which allows to concentrate the electrical flow and stimulate a deep, more physiological area, further limiting the risk of phrenic stimulation.
- the screw 14 is an active screw, that is to say playing (at least at its distal end) the role of stimulation electrode.
- the screw may be an electrically passive screw serving only for anchoring the probe head against the wall of the epicardium, the probe head being in the latter case provided at its end with a distal electrode. specific, for example in the form of stimulation ring.
- the guide catheter 24 used for implanting the probe at the selected stimulation site has been illustrated with the probe 10 inserted therein. The distal portion of this guide catheter 24 is open at its end, so as to be able to emerge the distal end of the probe 10 and its anchoring screw 14 by relative axial displacement of the probe body 12 inside the guide catheter 24.
- This guide catheter 24 has at its distal portion a double curvature 26, 28, each of these curvatures being inscribed in a respective distinct surface 30, 32.
- the curvilinear surface 30 defines a curvature 26 (hereinafter “support curvature”) which not only allows the relatively spherical curvature to naturally follow during the progression of the guide catheter into the pericardial space, but which also allows, when the site of implantation was chosen, to create a support against the inner wall of the pericardial sac so as to keep in place the guide catheter in the latter despite the heartbeat.
- This curvilinear portion 30 has an overall dimension in plan (corresponding to the view from above of the Figure 6 ) of the order of 15-25 mm over 10-15 mm.
- the curvilinear surface 32 defines a curvature 28 (hereinafter “orientation curvature”) making it possible to direct the probe head, and therefore the axis of the anchor screw, towards the wall of the myocardium according to a predefined angle of attack.
- This curvilinear portion 32 has an overall dimension in elevation (corresponding to the end view of the Figure 5 ) of the order of 10-15 mm over 5 mm at most.
- the double curvature 26, 28 fits into a parallelepipedal volume of dimensions of between 15 ⁇ 10 ⁇ 5 mm and 25 ⁇ 15 ⁇ 5 mm, which dimensions are compatible with the positioning in the pericardial space and the functions sought to maintain and guide the probe head.
- the reference 34 designates the myocardium itself, that is to say the cardiac muscle, which is wrapped in a fibroserosal sac or "pericardial sac" 36 defining between the outer wall of the myocardium and its inner wall a pericardial space 38 , filled with a small amount of fluid and to facilitate the movement of the heart inside the chest.
- the diameter of the guide catheter is chosen to be sufficiently thin, typically 9 French or even 6 French, to allow easy navigation in the pericardial space 38. It is also possible to use a guide catheter 6 French strengthened by a guide catheter 9 French standard, the assembly providing a telescopic function and to increase the rigidity of the body to improve control, according to a procedure in itself conventional.
- the practitioner maintains the guide catheter 24 in position by applying a torque to a handle (not shown) located at the proximal end of the guide catheter. Because of the curvature 26, the guide catheter 24 then bears at 40 against the outer wall of the pericardial space 38, thus generating a resisting torque in the opposite direction which constrains the distal end of the guide catheter in place, and therefore the probe, which is then maintained in support of the chosen site of implantation, while following the movements of the heart beats.
- the curvature of orientation 28 at the distal end has the effect of directing the axis of the anchoring screw 14 not in the extension of the pericardial space 38, but on the contrary, as illustrated Figure 4 (after removal of the guide catheter) to the outer wall of the myocardium 34 with a predetermined angle of attack. In this way, the attachment of the screw and the subsequent screwing thereof will be guided in a direction D making an angle ⁇ with the axial general direction of the probe.
- the practitioner slides the probe 10 inside the guide catheter 24, until the distal end of this probe and its anchor screw 14 emerge from the corresponding end of the catheter.
- -guide illustrated configuration Figure 2 . Due to the double curvature described above of the distal end of the guide catheter 24, the distal orifice of the guide catheter is directed towards the outer wall of the myocardium 34 at an angle ⁇ relative to the general direction of the catheter. pericardial space. It is enough then to advance in this guide catheter the probe 10 until it opens out of the guide catheter so that its anchor screw comes into contact with this wall 34.
- the final anchorage is obtained by printing an axial rotational movement to the probe body (in the case of a fixed screw probe) or to the plug of the connector (for a pin driven probe , where on the proximal side the plug connection is secured to an axial conductor extending inside the probe body, this conductor itself being free in rotation and connected to the anchor screw at its distal end).
- Yet another possibility is to introduce into the lumen of the probe body a specific screwing mandrel, especially when the sheath does not have sufficient torsional rigidity to drive the screw directly from the proximal end.
- the last step is to remove the guide catheter 24, which is done according to a conventional cutting procedure by means of a slitter- type tool such as that described in FIG. EP 2 039 390 A1 (ELA Medical).
- the final and definitive configuration is the one illustrated Figure 4 .
- the head of the probe is no longer held by the guide catheter carrier, it then articulates in the direction of the probe body, thanks to the flexible transition portion 22, thus limiting the maximum grip in the direction of the thickness of the pericardial space.
Abstract
Description
L'invention concerne les "dispositifs médicaux implantables actifs" tels que définis par la directive 90/385/CEE du 20 juin 1990 du Conseil des communautés européennes, notamment les implants permettant de surveiller en continu le rythme cardiaque et délivrer si nécessaire au coeur des impulsions électriques de stimulation, de resynchronisation, ou de défibrillation.The invention relates to "active implantable medical devices" as defined by the Council of European Communities Directive 90/385 / EEC of 20 June 1990, in particular implants for continuously monitoring the heart rate and delivering, if necessary, the heart of electrical pulses of stimulation, resynchronization, or defibrillation.
Elle concerne plus précisément les sondes dites "épicardiques" qui sont fixées sur la paroi extérieure du coeur, par opposition aux sondes dites "endocardiaques" qui sont logées dans une cavité du coeur où elles y sont introduites via le réseau veineux.It concerns more precisely the so-called "epicardial" probes which are fixed on the outer wall of the heart, as opposed to so-called "endocardiac" probes which are housed in a cavity of the heart where they are introduced via the venous network.
On fera surtout référence dans la suite aux sondes de stimulation, c'est-à-dire de délivrance d'impulsions à basse énergie, utilisées pour les thérapies antibradycardiques ou de resynchronisation. Mais l'invention s'applique également aux sondes épicardiques de cardioversion/défibrillation destinées à délivrer au coeur des chocs électriques de haute énergie pour tenter de mettre fin à une tachyarythmie. On utilisera le terme générique de "sonde (ou électrode) de stimulation/défibrillation" pour désigner tout type de sonde utilisable à ces fins.Reference will be made below to the stimulation probes, that is to say the delivery of low energy pulses, used for bradycardia or resynchronization therapy. However, the invention also applies to epicardial cardioversion / defibrillation probes intended to deliver high energy electrical shocks to the heart in an attempt to terminate a tachyarrhythmia. The generic term "stimulation / defibrillation probe (or electrode)" will be used to refer to any type of probe that can be used for these purposes.
Les sondes épicardiques peuvent être notamment prescrites pour la stimulation du ventricule gauche, en alternative aux sondes de stimulation implantées via le sinus coronaire, qui nécessitent pour leur pose une approche délicate et ne sont pas dénuées d'inconvénients divers.The epicardial probes can be especially prescribed for the stimulation of the left ventricle, as an alternative to the stimulation probes implanted via the coronary sinus, which require for their installation a delicate approach and are not without various disadvantages.
A la différence des sondes endocavitaires introduites via le réseau veineux, la mise en place d'une sonde épicardique est une opération très invasive, nécessitant généralement une anesthésie générale et le recours à des techniques chirurgicales. Il est en effet nécessaire qu'un chirurgien incise le thorax de manière à ménager un accès au "sac péricardique" (le péricarde étant l'enveloppe fibro-séreuse qui enveloppe le coeur), puis au myocarde lui-même, afin de pouvoir fixer la sonde sur la paroi externe de ce dernier, par suturation ou par vissage.Unlike endocavity probes introduced via the venous network, the setting up of an epicardial probe is a very invasive operation, generally requiring general anesthesia and the use of surgical techniques. It is indeed necessary for a surgeon to incise the thorax so as to allow access to the "pericardial sac" (the pericardium being the fibroserous envelope which envelops the heart), then to the myocardium itself, in order to fix the probe on the outer wall of the latter, by suturation or by screwing.
Plusieurs types de sondes épicardiques ont été proposées, mais toutes présentent un certain nombre d'inconvénients assez sérieux.Several types of epicardial probes have been proposed, but all have a number of rather serious disadvantages.
Les sondes suturées sont très stables, mais elles nécessitent un large accès (pour permettre la suture par le chirurgien), et la zone de pose possible, restreinte à la proximité de l'incision thoracique, est très limitée.The sutured probes are very stable, but they require wide access (to allow suture by the surgeon), and the possible pose area, restricted to the proximity of the thoracic incision, is very limited.
On a également proposé des sondes à visser. Le vissage peut se faire directement, mais la zone de travail sera limitée de la même façon que pour une sonde suturée. Il peut également se faire au moyen d'un instrument de pose comprenant un manche, un tube support télescopique et une tête articulée sur laquelle est montée la sonde. Dans ce dernier cas, le chirurgien pourra accéder à des sites situés au-delà de l'incision, mais la zone de pose possible sera toutefois limitée par la rigidité du tube support de l'instrument, et par le diamètre important de ce tube (de l'ordre de 40 French), que le médecin doit faire progresser dans l'espace péricardique courbe.Screw probes have also been proposed. The screwing can be done directly, but the working area will be limited in the same way as for a sutured probe. It can also be done by means of a laying instrument comprising a handle, a telescopic support tube and an articulated head on which is mounted the probe. In the latter case, the surgeon will be able to access sites located beyond the incision, but the possible pose area will however be limited by the rigidity of the support tube of the instrument, and by the large diameter of this tube ( of the order of 40 French), which the doctor must advance in the curved pericardial space.
En tout état de cause, les sondes à vis proposées jusqu'à présent présentent de faibles performances électriques en raison de la taille importante de la vis (nécessaire pour supporter les conditions de pose mais qui ne procure pas une densité de courant satisfaisante). De plus, ces vis de fixation sont relativement traumatiques pour les tissus, avec risque de création localement de fibroses réactionnelles.In any case, the screw probes proposed so far have low electrical performance due to the large size of the screw (necessary to support the conditions of installation but does not provide a satisfactory current density). In addition, these fixation screws are relatively traumatic for the tissues, with the risk of locally creating reactive fibrosis.
Il est toutefois important, sur le plan mécanique, que les vis des sondes actuelles soient surdimensionnées, en raison des contraintes élevées exercées lors de la pose sur la vis, avec des accessoires très volumineux et offrant peu de sensibilité. La tête de sonde y est soumise à des contraintes mécaniques importantes dues à de fortes amplitudes de déplacement, combinées aux tractions radiales exercées via le corps de sonde. L'ancrage mécanique de la tête de sonde sur le myocarde doit donc être capable de résister à ces diverses contraintes.However, it is important, mechanically, that the screws of current probes are oversized, because of the high stresses exerted when laying on the screw, with very bulky accessories and low sensitivity. The probe head is subjected to significant mechanical stresses due to high displacement amplitudes, combined with radial tractions exerted via the probe body. The mechanical anchoring of the probe head on the myocardium must therefore be able to withstand these various constraints.
Une autre caractéristique commune à la quasi-totalité des sondes épicardiques actuelles est le fait que le corps de sonde (la gaine reliant la tête de sonde au générateur de stimulation) se raccorde à angle droit à la tête de sonde, c'est-à-dire que l'axe de la gaine est perpendiculaire à l'axe de la vis. Ceci donne à l'ensemble une configuration volumineuse, donc traumatique dans la région du site de stimulation.Another characteristic common to almost all current epicardial probes is that the probe body (the sheath connecting the probe head to the stimulation generator) connects at right angles to the probe head, ie that is, that the axis of the sheath is perpendicular to the axis of the screw. This gives the whole a voluminous configuration, so traumatic in the region of the stimulation site.
Enfin, la géométrie de ces sondes rend impossible leur retrait par simple vissage et nécessite une intervention lourde.Finally, the geometry of these probes makes it impossible to remove them by simple screwing and requires heavy intervention.
Le but de l'invention est de proposer un nouveau type de sonde épicardique, et un accessoire de pose de cette sonde, qui pallient l'ensemble des inconvénients évoqués ci-dessus, en permettant notamment de :
- limiter la dimension de l'incision pour l'accès au coeur, celle-ci pouvant être réduite, comme on le verra, à une simple ponction ;
- miniaturiser la tête de sonde pour la rendre moins traumatique ;
- miniaturiser l'accessoire de pose, de manière à offrir une plus grande sensibilité au praticien et rendre l'intervention moins invasive ;
- maximiser la zone de travail autour du point d'entrée dans l'enveloppe péricardique, et donc l'étendue des sites de stimulation potentiels ;
- augmenter la manoeuvrabilité pour le choix du site ;
- permettre une voie d'accès ne nécessitant pas une tunnellisation ;
- offrir une possibilité de "mapping" avant le vissage définitif de la sonde, c'est-à-dire de test de la réponse électrique du site d'implantation envisagé ;
- assurer sur le plan mécanique une fixation de qualité, mais moins traumatique pour les tissus ;
- accroître les performances électriques ;
- autoriser une extraction par des moyens simples ;
- offrir une configuration de type "isodiamètre" (ou "monodiamètre") compatible avec les techniques chirurgicales d'implantation courantes.
- limit the size of the incision for access to the heart, which can be reduced, as we shall see, to a simple puncture;
- miniaturize the probe head to make it less traumatic;
- miniaturize the fitting accessory, so as to offer greater sensitivity to the practitioner and make the intervention less invasive;
- maximize the area of work around the point of entry into the pericardial envelope, and thus the extent of potential stimulation sites;
- increase maneuverability for site selection;
- allow an access route that does not require tunneling;
- offer a possibility of "mapping" before the final screwing of the probe, that is to say of testing the electrical response of the proposed implantation site;
- mechanically secure a fixation of quality, but less traumatic for the tissues;
- increase electrical performance;
- allow extraction by simple means;
- offer an "isodiameter" (or "monodiameter") type configuration that is compatible with current surgical implantation techniques.
Le principe de base de l'invention consiste à choisir comme sonde épicardique une sonde à vis, mais dont la vis s'étend dans le prolongement du corps de sonde (et non plus à 90° par rapport à ce dernier), avec une vis de taille et de caractéristiques comparables à celles des sondes endocavitaires à vis.The basic principle of the invention is to choose as an epicardial probe a screw probe, but whose screw extends in the extension of the probe body (and no longer at 90 ° relative to the latter), with a screw similar in size and characteristics to endocavitary screw probes.
L'invention propose en outre, pour la mise en place d'une telle sonde sur la paroi externe du myocarde, d'utiliser comme outil de pose un cathéter-guide dans lequel sera glissée la sonde. Ce cathéter-guide pourra être introduit dans l'espace péricardique par une simple ponction (donc sans incision de l'enveloppe péricardique), et il sera possible de le faire évoluer autour de la surface, approximativement sphérique, du myocarde, pour "naviguer" ainsi sur l'épicarde en toute sécurité (du fait de la flexibilité du cathéter-guide et de son embout soft tip atraumatique) jusqu'au site de stimulation choisi, qui pourra être très éloigné de la ponction constituant le point d'accès à l'espace péricardique.The invention further proposes, for the establishment of such a probe on the outer wall of the myocardium, to use as a setting tool a guide catheter into which the probe will be slid. This catheter-guide can be introduced into the pericardial space by a simple puncture (thus without incision of the pericardial envelope), and it will be possible to make it evolve around the surface, approximately spherical, of the myocardium, to "navigate" and on the epicardium safely (because of the flexibility of the guide catheter and its soft tip tip atraumatic) to the chosen site of stimulation, which can be very far from the puncture constituting the access point to the pericardial space.
Le
Un tel cathéter, s'il était combiné à une sonde à vis, permettrait certes le vissage mais limiterait très sensiblement les capacités d'évoluer sur une large région à la surface du coeur. En effet, les larges courbes du heart-wrapping tendent en permanence à coïncider avec la forme externe du coeur, par le principe de moindre énergie. Il en résulte une position d'équilibre donnée (donc un site d'implantation donné) pour une courbure donnée, d'où la nécessité de plusieurs modèles (différentes courbures) si l'on veut plusieurs sites d'implantation possibles.Such a catheter, if combined with a screw probe, would certainly allow screwing but would very significantly limit the ability to evolve over a wide region on the surface of the heart. Indeed, the broad curves of the heart-wrapping tend permanently to coincide with the external form of the heart, by the principle of less energy. This results in a given equilibrium position (thus a given implantation site) for a given curvature, hence the need for several models (different curvatures) if one wants several possible implantation sites.
La divulgation du
- de naviguer librement dans l'espace péricardique sans être gêné par le principe de moindre énergie ;
- une fois le site choisi, d'orienter l'extrémité de la courbure d'appui dans la bonne direction (en ne laissant la possibilité que de deux positions angulaires stables facilement différenciables, à savoir : vers l'épicarde ou vers le sac péricardique) ; et
- de sécuriser la position retenue par un couple manuel exercé côté proximal.
- to navigate freely in the pericardial space without being bothered by the principle of lesser energy;
- once the site is chosen, orient the end of the support curvature in the right direction (leaving the possibility of only two stable angular positions easily distinguishable, namely: towards the epicardium or towards the pericardial sac) ; and
- to secure the position retained by a manual torque exerted proximal side.
Une autre technique encore, décrite par le
Si l'on veut combiner un cathéter-guide introduit dans l'espace péricardique avec une sonde à vis, le problème est dans tous les cas d'assurer une stabilisation du cathéter-guide une fois le site choisi, de manière à permettre le vissage de la tête de sonde pour fixer celle-ci définitivement. Pour cela, selon l'invention, le cathéter-guide est un cathéter préformé avec deux courbures successives dans sa région distale :
- la première courbure (la plus éloignée de l'extrémité du cathéter-guide) est une courbure d'appui permettant au cathéter-guide de s'appuyer sur la paroi extérieure du sac péricardique sous l'effet d'un couple de torsion imprimé par le praticien, et permettant de stabiliser en place le cathéter-guide en dépit des sollicitations diverses notamment sous l'effet des battements du coeur ;
- l'autre courbure, située à proximité de l'extrémité distale du cathéter-guide, est une courbure d'orientation permettant de tourner l'axe de la vis d'ancrage vers la paroi externe du myocarde, en formant avec cette dernière un angle suffisant pour y permettre le vissage selon un angle d'attaque prédéfini.
- the first curvature (furthest from the tip of the guide catheter) is a bearing curve allowing the guide catheter to rest on the outer wall of the pericardial sac under the effect of a torsion torque printed by the practitioner, and to stabilize in place the guide catheter in spite of the various sollicitations in particular under the effect of the beats of the heart;
- the other curvature, located near the distal end of the guide catheter, is an orientation curvature for rotating the axis of the anchor screw to the outer wall of the myocardium, forming with the latter an angle sufficient to allow screwing to a predefined angle of attack.
Les faibles dimensions de la sonde et du cathéter-guide (typiquement de l'ordre de 6 à 9 French), combinées à l'isodiamétrie de la sonde, font qu'il suffit d'une simple ponction pour introduire le cathéter-guide et la sonde, sans incision du sac péricardique.The small dimensions of the catheter and the catheter-guide (typically of the order of 6 to 9 French), combined with the isodiametry of the probe, make it enough for a simple puncture to introduce the catheter guide and the probe, without incision of the pericardial sac.
D'autre part, le caractère monodiamètre de la sonde est très favorable à l'extraction, qui pourra être opérée simplement par dévissage et retrait, sans intervention chirurgicale lourde.On the other hand, the monodiameter character of the probe is very favorable to the extraction, which can be operated simply by unscrewing and withdrawal, without heavy surgery.
Plus précisément, l'ensemble de l'invention comprend, de manière en elle-même connue, une sonde épicardique de stimulation/défibrillation de type sonde à vis, comportant : un corps de sonde avec une gaine en matériau déformable ; côté distal, une tête de sonde avec une électrode de stimulation/défibrillation et une vis d'ancrage hélicoïdale saillante apte à pénétrer dans la paroi externe du myocarde sous l'effet d'un mouvement de vissage imprimé à la tête de sonde ; et côté proximal, des moyens de couplage au générateur du dispositif médical. L'ensemble comprend également un accessoire de pose de cette sonde épicardique.More specifically, the assembly of the invention comprises, in a manner known per se, an epicardial probe of stimulation / defibrillation type screw probe, comprising: a probe body with a sheath of deformable material; distal side, a probe head with a stimulation / defibrillation electrode and a protruding helical anchoring screw adapted to penetrate the outer wall of the myocardium under the effect of a screwing motion printed at the probe head; and proximal side, coupling means to the generator of the medical device. The set also includes a fitting accessory for this epicardial probe.
De façon caractéristique de l'invention, la sonde est une sonde monodiamètre avec la vis d'ancrage hélicoïdale prolongeant axialement la tête de sonde, et l'accessoire de pose est un cathéter-guide amovible apte à être introduit dans l'espace péricardique. Ce cathéter-guide comprend un tube creux ouvert à ses deux extrémités avec une lumière centrale à l'intérieur de laquelle la sonde est apte à être introduite et déplacée en translation à l'intérieur du cathéter-guide, d'abord jusqu'à une position rétractée où la tête de sonde affleure le débouché côté distal de la lumière du cathéter-guide, puis jusqu'à une position déployée où la tête de sonde, avec la vis d'ancrage, émerge de ce débouché. Le tube creux du cathéter-guide est un tube préformé, élastiquement déformable et relativement plus rigide que la gaine du corps de sonde, et présentant en l'absence de sollicitation deux courbures successives inscrites dans deux surfaces respectives distinctes. La courbure la moins distale est une courbure adaptée pour permettre un appui du corps de sonde contre la paroi externe de l'espace péricardique, et la courbure la plus distale est une courbure adaptée pour permettre une orientation de l'extrémité du tube de cathéter dans la direction de la paroi externe du myocarde, et de maintien de l'axe de la vis d'ancrage dans cette même direction lors d'un mouvement combiné de vissage et de déplacement de la tête de sonde vers la position déployée. La vis d'ancrage peut être une vis fixe, ou bien une vis mobile, rétractable dans un logement de la tête de sonde. Elle peut être une vis active formant électrode de stimulation/défibrillation, ou bien une vis passive, électriquement découplée de l'électrode de stimulation/défibrillation.In a characteristic manner of the invention, the probe is a monodiameter probe with the helical anchoring screw extending axially the probe head, and the fitting accessory is a removable guide catheter adapted to be introduced into the pericardial space. This guide catheter comprises a hollow tube open at both ends with a central lumen within which the probe is adapted to be introduced and moved in translation inside the guiding catheter, first up to a retracted position where the probe head is flush with the outlet distal side of the lumen of the guide catheter, and then to an extended position where the probe head, with the anchor screw, emerges from this outlet. The hollow tube of the guide catheter is a preformed tube, elastically deformable and relatively more rigid than the sheath of the probe body, and presenting in the absence of solicitation two successive curvatures inscribed in two distinct respective surfaces. The least distal curvature is a curvature adapted to allow a bearing of the probe body against the outer wall of the pericardial space, and the most distal curvature is a curvature adapted to allow orientation of the end of the catheter tube in the direction of the outer wall of the myocardium, and maintaining the axis of the anchor screw in the same direction during a combined movement of screwing and moving the probe head to the deployed position. The anchoring screw may be a fixed screw, or a movable screw, retractable in a housing of the probe head. It may be an active pacing / defibrillation electrode screw, or a passive screw, electrically decoupled from the pacing / defibrillation electrode.
La gaine du corps de sonde peut être choisie pour présenter en torsion une rigidité suffisante pour permettre la transmission sur toute sa longueur d'un mouvement de rotation imprimé depuis l'extrémité proximale de la sonde, pour le vissage de la vis d'ancrage.The sheath of the probe body may be chosen to have a torsion rigidity sufficient to allow transmission over its entire length of a rotational movement printed from the proximal end of the probe for screwing the anchor screw.
Dans le cas contraire, l'ensemble comprendra en outre un mandrin amovible, apte à être introduit dans une lumière du corps de sonde et mobile en translation à l'intérieur de cette lumière jusqu'à la tête de sonde et comportant des moyens de couplage en rotation avec la tête de sonde, ce mandrin présentant en torsion une rigidité suffisante pour permettre la transmission, sur toute sa longueur et jusqu'aux moyens de couplage, d'un mouvement de rotation imprimé depuis l'extrémité proximale du mandrin, pour le vissage de la vis d'ancrage.In the opposite case, the assembly will also comprise a removable mandrel capable of being introduced into a lumen of the probe body and movable in translation inside this lumen to the probe head and comprising coupling means. in rotation with the probe head, the mandrel having a torsion sufficient rigidity to allow transmission, over its entire length and up to the coupling means, a rotational movement printed from the proximal end of the mandrel, for the screwing in the anchor screw.
De préférence, le diamètre du cathéter-guide est inférieur ou égal à 9 French, de préférence inférieur ou égal à 6 French, et celui du corps de sonde est inférieur ou égal à 5 French.Preferably, the diameter of the guide catheter is less than or equal to 9 French, preferably less than or equal to 6 French, and that of the probe body is less than or equal to 5 French.
Avantageusement, la vis d'ancrage comprend une partie d'extrémité apte à pénétrer dans la paroi externe du myocarde, et reliée à la tête de sonde par une partie de transition mécaniquement déformable en flexion, notamment une partie à spires jointives de la vis hélicoïdale.Advantageously, the anchoring screw comprises an end portion adapted to penetrate into the outer wall of the myocardium, and connected to the probe head by a transition portion that is mechanically deformable in flexion, in particular a portion with contiguous turns of the helical screw. .
La vis d'ancrage peut aussi comporter une partie d'extrémité apte à pénétrer dans la paroi externe du myocarde, et comprenant elle-même une région active de pointe électriquement conductrice, prolongeant une partie intermédiaire électriquement isolée, dont la longueur axiale est de préférence d'au plus 1 mm.The anchoring screw may also comprise an end portion adapted to penetrate the outer wall of the myocardium, and itself comprising an active region of electrically conductive tip, extending a portion electrically isolated intermediate, the axial length of which is preferably at most 1 mm.
En ce qui concerne les courbures successives, celles-ci s'inscrivent dans un volume parallélépipédique de dimensions comprises entre 15 x 10 x 5 mm et 25 x 15 x 5 mm, compatibles avec le positionnement dans l'espace péricardique et les fonctions recherchées de maintien et de guidage de la tête de sonde.
0As regards the successive curvatures, these form part of a parallelepiped volume of dimensions between 15 × 10 × 5 mm and 25 × 15 × 5 mm, compatible with the positioning in the pericardial space and the desired functions of holding and guiding the probe head.
0
On va maintenant décrire un exemple de réalisation de l'invention, en référence aux dessins annexés où les mêmes références numériques désignent d'une figure à l'autre des éléments identiques ou fonctionnellement semblables.
- La
Figure 1 est une vue en coupe de la tête de sonde de l'ensemble selon l'invention. - La
Figure 2 illustre schématiquement la configuration de l'ensemble constitué par la sonde de laFigure 1 , combinée à un cathéter-guide à double courbure et à un mandrin introduit dans la sonde, cette illustration étant vue en perspective montrant la forme de l'ensemble dans l'espace. - La
Figure 3 est une vue partielle en coupe montrant les différentes tuniques du coeur et illustrant la manière dont l'ensemble cathéter-sonde selon l'invention est introduit et positionné dans le sac péricardique. - La
Figure 4 est une vue en coupe de la sonde de laFigure 1 après que celle-ci ait été implantée dans l'espace péricardique, avec la vis ancrée dans la paroi externe du myocarde. - La
Figure 5 est une vue de bout selon V-V de laFigure 2 . - La
Figure 6 est une vue de dessus, selon VI-VI de laFigure 2 .
- The
Figure 1 is a sectional view of the probe head of the assembly according to the invention. - The
Figure 2 schematically illustrates the configuration of the assembly constituted by the probe of theFigure 1 combined with a double-curved guide catheter and a mandrel inserted into the probe, this illustration being perspective view showing the shape of the assembly in space. - The
Figure 3 is a partial sectional view showing the different tunics of the heart and illustrating how the catheter-probe assembly according to the invention is introduced and positioned in the pericardial sac. - The
Figure 4 is a sectional view of the probe of theFigure 1 after this has been implanted in the pericardial space, with the screw anchored in the outer wall of the myocardium. - The
Figure 5 is an end view according to VV of theFigure 2 . - The
Figure 6 is a view from above, according to VI-VI of theFigure 2 .
On va maintenant décrire un exemple de réalisation de l'invention.An embodiment of the invention will now be described.
Sur les figures, la référence 10 désigne de façon générale la sonde à vis de l'ensemble selon l'invention. Cette sonde 10 comporte un corps de sonde 12 de structure en elle-même connue, généralement une gaine en polyuréthanne pour limiter les frottements lorsque la sonde est introduite dans un cathéter-guide, et pour procurer une meilleure sensibilité et une meilleure transmission du couple de torsion. Le diamètre de la gaine du corps de sonde 12 est choisi suffisamment fin (typiquement inférieur ou égal à 5 French) pour être compatible avec les dimensions de l'espace péricardique et avec le diamètre des cathéters-guides usuels.In the figures, the
La sonde 10 est terminée à son extrémité distale par une vis d'ancrage hélicoïdale 14 en matériau conducteur, reliée par l'intermédiaire d'un embout métallique 16 à un conducteur interne 18 tel qu'un conducteur spiralé assurant la continuité électrique entre la vis d'ancrage, qui fait office d'électrode de stimulation et/ou de recueil, et le générateur situé à l'extrémité proximale (non représentée) de la sonde. On notera que la gaine en polyuréthanne peut être choisie pour procurer une certaine rigidité en torsion au corps de sonde 12, de manière à pouvoir transmettre un couple de torsion depuis l'extrémité proximale jusqu'à l'extrémité distale afin d'entraîner en rotation la vis 14 pour la faire pénétrer par vissage dans le tissu cardiaque.The
A la différence des sondes épicardiques classiques où la vis s'étend à angle droit par rapport au corps de sonde auquel elle est raccordée, la vis d'ancrage 14 est ici une vis axiale, c'est-à-dire qu'elle s'étend dans le prolongement du corps de sonde 12, procurant ainsi à l'ensemble une configuration d'ensemble de type "isodiamètre" ou "monodiamètre".Unlike conventional epicardial probes where the screw extends at right angles to the probe body to which it is connected, the
La vis 14 est avantageusement réalisée avec une partie distale formée, sur une longueur de l'ordre de 1,5 à 2 mm, de spires non jointives 20 reliées au corps de sonde par l'intermédiaire d'une partie de transition mécanique présentant une souplesse en flexion, par exemple une partie formée de spires 22 jointives en l'absence de sollicitation de la vis.The
La vis 14 est avantageusement isolée sur toute sa longueur, par exemple par un revêtement de parylène, à l'exception du dernier millimètre distal qui sera donc la seule partie électriquement active de la vis, ce qui permet de diminuer la surface de stimulation et accroître d'autant la densité de courant et donc l'efficacité électrique de la sonde. Cette partie électriquement active sera en outre enfouie assez profondément dans la paroi de l'épicarde, ce qui permet d'y concentrer le flux électrique et de stimuler une zone profonde, plus physiologique, en limitant de surcroît le risque de stimulation phrénique.The
Dans le mode de réalisation illustré, la vis 14 est une vis active, c'est-à-dire jouant (au moins à son extrémité distale) le rôle d'électrode de stimulation. En variante, la vis peut être une vis électriquement passive ne servant qu'à l'ancrage de la tête de sonde contre la paroi de l'épicarde, la tête de sonde étant dans ce dernier cas pourvue à son extrémité d'une électrode distale spécifique, par exemple en forme d'anneau de stimulation. Sur la
Ce cathéter-guide 24 présente à sa partie distale une double courbure 26, 28, chacune de ces courbures étant inscrite dans une surface distincte respective 30, 32.This
La surface curviligne 30 définit une courbure 26 (ci-après "courbure d'appui") qui non seulement permet de suivre naturellement la courbure relativement sphérique lors de la progression du cathéter-guide dans l'espace péricardique, mais qui permet également, lorsque le site d'implantation a été choisi, de créer un appui contre la paroi intérieure du sac péricardique de manière à maintenir en place le cathéter-guide dans ce dernier en dépit des battements cardiaques. Cette partie curviligne 30 présente une dimension hors-tout en plan (correspondant à la vue de dessus de la
La surface curviligne 32, quant à elle, définit une courbure 28 (ci-après "courbure d'orientation") permettant de diriger la tête de sonde, et donc l'axe de la vis d'ancrage, vers la paroi du myocarde selon un angle d'attaque prédéfini. Cette partie curviligne 32 présente une dimension hors-tout en élévation (correspondant à la vue de bout de la
En d'autres termes, la double courbure 26, 28 s'inscrit dans un volume parallélépipédique de dimensions comprises entre 15 x 10 x 5 mm et 25 x 15 x 5 mm, dimensions compatibles avec le positionnement dans l'espace péricardique et les fonctions recherchées de maintien et de guidage de la tête de sonde.In other words, the
La référence 34 désigne le myocarde proprement dit, c'est-à-dire le muscle cardiaque, qui est enveloppé dans un sac fibro-séreux ou "sac péricardique" 36 définissant entre la paroi externe du myocarde et sa paroi interne un espace péricardique 38, rempli d'une faible quantité de liquide et permettant de faciliter les mouvements du coeur à l'intérieur du thorax.The
Le diamètre du cathéter-guide est choisi suffisamment fin, typiquement 9 French, voire 6 French, pour permettre une navigation aisée dans l'espace péricardique 38. Il est également possible d'utiliser un cathéter-guide 6 French renforcé par un cathéter-guide 9 French standard, l'ensemble assurant une fonction télescopique et permettant d'augmenter la rigidité du corps pour en améliorer le contrôle, selon une procédure en elle-même classique.The diameter of the guide catheter is chosen to be sufficiently thin, typically 9 French or even 6 French, to allow easy navigation in the
Une fois le site de stimulation identifié, le praticien maintient le cathéter-guide 24 en position en appliquant un couple de torsion sur une poignée (non représentée) située à l'extrémité proximale du cathéter-guide. Du fait de la courbure 26, le cathéter-guide 24 vient alors en appui en 40 contre la paroi externe de l'espace péricardique 38, générant ainsi un couple résistant en sens inverse qui contraint en place l'extrémité distale du cathéter-guide, et donc de la sonde, qui se trouve alors maintenue en appui sur le site d'implantation choisi, tout en suivant les mouvements des battements cardiaques.Once the stimulation site has been identified, the practitioner maintains the
La courbure d'orientation 28 à l'extrémité distale a pour effet de diriger l'axe de la vis d'ancrage 14 non pas dans le prolongement de l'espace péricardique 38, mais au contraire, comme illustré
Une fois le site atteint, le praticien fait coulisser la sonde 10 à l'intérieur du cathéter-guide 24, jusqu'à ce que l'extrémité distale de cette sonde et sa vis d'ancrage 14 émergent de l'extrémité correspondante du cathéter-guide (configuration illustrée
Il est alors possible de procéder à un mapping préalable pour tester électriquement le point de contact et valider le site de stimulation choisi. Si la position n'est pas satisfaisante, il suffit au praticien de déplacer sous contrôle le cathéter-guide dans le sac péricardique vers un autre point et de tester un nouveau site.It is then possible to perform a pre- mapping to electrically test the point of contact and validate the chosen stimulation site. If the position is not satisfactory, it is sufficient for the practitioner to move the guiding catheter under control in the pericardial sac to another point and to test a new site.
L'ancrage définitif est obtenu en imprimant un mouvement de rotation axiale au corps de sonde (dans le cas d'une sonde à vis fixe) ou à la fiche du connecteur (pour une sonde de type pin driven, où du côté proximal la fiche de connexion est solidaire d'un conducteur axial s'étendant à l'intérieur du corps de sonde, ce conducteur étant lui-même libre en rotation et relié à la vis d'ancrage à son extrémité distale). Une autre possibilité encore consiste à introduire dans la lumière du corps de sonde un mandrin de vissage spécifique, ceci notamment lorsque la gaine ne présente pas une rigidité en torsion suffisante pour entraîner la vis directement depuis l'extrémité proximale.The final anchorage is obtained by printing an axial rotational movement to the probe body (in the case of a fixed screw probe) or to the plug of the connector (for a pin driven probe , where on the proximal side the plug connection is secured to an axial conductor extending inside the probe body, this conductor itself being free in rotation and connected to the anchor screw at its distal end). Yet another possibility is to introduce into the lumen of the probe body a specific screwing mandrel, especially when the sheath does not have sufficient torsional rigidity to drive the screw directly from the proximal end.
En variante, au lieu d'une vis fixe, il est possible d'utiliser une vis de type vis rétractable, avec un mécanisme en lui-même connu. Dans ce cas, le mouvement de rotation entraîne tout d'abord le déploiement de la vis hors de son logement, puis dans un second temps la pénétration de celle-ci dans la paroi du myocarde.Alternatively, instead of a fixed screw, it is possible to use a retractable screw type screw, with a mechanism in itself known. In this case, the rotational movement first causes the deployment of the screw out of its housing, then in a second time the penetration thereof into the wall of the myocardium.
La dernière étape consiste à retirer le cathéter-guide 24, ce qui est fait selon une procédure classique de découpe au moyen d'un outil de type slitter tel que celui décrit dans le
La configuration finale, et définitive, est celle illustrée
La tête de la sonde n'étant plus maintenue par le cathéter-guide porteur, elle s'articule alors en direction du corps de sonde, grâce à la partie de transition flexible 22, limitant ainsi au maximum l'emprise dans le sens de l'épaisseur de l'espace péricardique.The head of the probe is no longer held by the guide catheter carrier, it then articulates in the direction of the probe body, thanks to the
Parmi les avantages de la technique que l'on vient d'exposer, on peut citer en particulier :
- technique très faiblement invasive : l'accès au sac péricardique ne se fait pas par une incision, mais par une simple ponction, c'est-à-dire un simple trou (dimension 9 French) réalisé à l'aiguille puis élargi, donc qui se refermera lui-même sans qu'il soit nécessaire de procéder à une suture et avec diminution des risques infectieux. Cette intervention légère peut être réalisée par un électrophysiologiste, sans recours à un chirurgien ;
- possibilité de mapper une large zone autour du point d'accès, et même dans des régions très éloignées, voire opposées de ce point d'accès, la navigation du cathéter-guide étant possible dans une très vaste étendue du sac péricardique ;
- la progression dans l'espace péricardique reste très atraumatique par rapport aux solutions actuelles : en effet, la recherche du site optimal se fait avec un cathéter-guide sécurisé par une sonde d'électrophysiologie, ou par un système classique dilatateur souple + fil-guide, à la différence des sondes actuelles où c'est la vis définitive - très agressive - qui est exposée en partie distale de l'accessoire de pose, avec risque de dissection du sac péricardique et/ou des tissus de surface. La navigation est en outre largement facilitée par la faible taille du cathéter-guide, typiquement un diamètre de 6 French ;
- performances électriques supérieures à celles des sondes proposées jusqu'à présent, grâce au découplage mécanique entre le corps de sonde et la vis du fait de la partie de transition flexible ;
- concentration du flux électrique dans une région profonde du myocarde ;
- excellente capacité d'extraction, par simple dévissage de l'extrémité distale : en particulier le caractère isodiamètre de la sonde facilite une telle extraction simplement par dévissage puis retrait ;
- simplicité mécanique d'ensemble, donc faible coût de fabrication et fiabilité élevée.
- very poorly invasive technique: access to the pericardial sac is not done by incision, but by a simple puncture, that is to say a single hole (size 9 French) made with the needle then widened, which will close itself without the need to perform a suture and with reduced infectious risks. This light intervention can be performed by an electrophysiologist without the need for a surgeon;
- possibility of mapping a large area around the access point, and even in very remote or even opposite regions of this access point, navigation of the guide catheter being possible in a very large extent of the pericardial sac;
- progression in the pericardial space remains very atraumatic compared to current solutions: in fact, the search for the optimal site is done with a guide catheter secured by an electrophysiology probe, or by a conventional dilator flexible + guide wire system , unlike current probes where it is the final screw - very aggressive - which is exposed in distal part of the fitting accessory, with risk of dissection of the pericardial sac and / or surface tissues. Navigation is also greatly facilitated by the small size of the guide catheter, typically a diameter of 6 French;
- electrical performance superior to that of the probes proposed so far, thanks to the mechanical decoupling between the probe body and the screw due to the flexible transition part;
- concentration of the electrical flow in a deep region of the myocardium;
- excellent extraction capacity, by simply unscrewing the distal end: in particular the isodiameter character of the probe facilitates such extraction simply by unscrewing and withdrawal;
- overall mechanical simplicity, so low manufacturing cost and high reliability.
Claims (14)
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FR0956982 | 2009-10-07 |
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EP10174448.0A Active EP2308550B1 (en) | 2009-10-07 | 2010-08-30 | Epicardial stimulation/defibrillation probe with screw, suitable for implantation via a catheter-guide inserted in the pericardial cavity |
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Cited By (1)
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EP2719424A1 (en) | 2012-10-12 | 2014-04-16 | Sorin CRM SAS | Intraseptal probe for left ventricular stimulation |
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WO2016090360A1 (en) * | 2014-12-05 | 2016-06-09 | Vquad Medical | Epicardial heart rhythm management devices, systems and methods |
CN107810028B (en) * | 2015-05-15 | 2021-06-25 | 美国政府(由卫生和人类服务部的部长所代表) | Three-dimensional right auricle bending catheter |
WO2017023382A1 (en) * | 2015-07-31 | 2017-02-09 | Curtis Guy P | System and method for electrode placement in the pericardial sac of a patient |
WO2017173433A1 (en) | 2016-04-01 | 2017-10-05 | Tholakanahalli Venkatakrishna N | Shaped epicardial lead and placement system and method |
EP3459592A1 (en) * | 2017-09-20 | 2019-03-27 | Sorin CRM SAS | Implantable lead |
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Also Published As
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US20110082466A1 (en) | 2011-04-07 |
EP2308550B1 (en) | 2016-01-13 |
US9427576B2 (en) | 2016-08-30 |
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